Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
What Verdye is Verdye is a dark-green powder, which is mixed with water for injections. The active substance in the solution is called indocyanine green, a coloured dye. This solution is injected into one of your veins, where it mixes with your blood. The doctor will then be able to see:
• how far the dye moves from where it was injected
• how much of it there is in various parts of your body.
What Verdye is used for It is used for diagnosis only , to find out which medical problems you may have, for example:
a) how well the blood is flowing through a part of your body, for example:
• your heart
• your brain
• your liver
• a layer of the inner part of your eye called the choroid
b) how much blood there is in certain parts of your body
c) how well your liver is working.
Do not use Verdye • if you are allergic to indocyanine green, sodium iodide or iodine
• if you suffer from an over-active thyroid or from benign tumours of the thyroid
• if you have ever had any side effects after receiving these injections.
Special patient groups Premature babies and new-born infants
If suffering from hyperbilirubinaemia (an illness in which there is an unusually large amount of bilirubin in their blood), premature babies and new-born infants should not receive Verdye.
Warnings and precautions Talk to your doctor or pharmacist before using Verdye,
• if you suffer from kidney failure. Consult your doctor to see whether this medicine is suitable for you.
• if you need to have a test called “radio-active iodine uptake”, a test which assesses how well your thyroid gland functions. This test should be delayed for at least a week after you have received Verdye, because the injection could affect the outcome of the thyroid test.
Other medicines and Verdye Tell your doctor or pharmacist if you are taking/using or have recently taken/used or might take/use any other medicines.
This applies especially
• if you are taking any drugs that affect the way your liver works, because the process of eliminating indocyanine green from your body after the injection may be affected.
• if you are taking/using, or think you may be taking/using, any of the drugs listed below, because some of these drugs could alter the way in which indocyanine green, the active substance in Verdye , is absorbed into the body, and could make the diagnosis inaccurate: • anticonvulsants (anti-epileptic drug)
• morphine (severe pain-relieving drug)
• any injections containing sodium bisulphite (preservative)
• nitrofurantoin (antibiotic)
• bisulphite compounds (preservative)
• opium alkaloids (anti-diarrhoea drugs)
• cyclopropane (anaesthetic drug)
• pethidine (severe pain-relieving drug)
• diamorphine (narcotic drug)
• phenobarbital (anti-epileptic and anaesthetic drug)
• haloperidol (antipsychotic drug)
• phenylbutazone (pain relieving drug)
• metamizole (pain relieving drug)
• probenecid (drug for gout therapy)
• methadone (drug for substitution treatment of opioid addicts)
• rifamycin (antibiotic)
Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you receive this medicine. Your doctor will decide if it is appropriate to give you this medicine.
Driving and using machines No studies on the effects on the ability to drive and use machines have been performed. Please check with your doctor before you consider driving or using machinery immediately after an injection.
The injection is given only under the supervision of a doctor.
• Only water for injections is used to dissolve the indocyanine green powder.
• The solution for injection has to be inspected before it is given to you. If it is cloudy, it will not be used.
• The doctor or nurse injects the medicine directly into a vein using a needle, catheter or cardiac (heart) catheter.
• The vein chosen for the injection will depend on the kind of investigation you are having.
• If this medicine is injected into a vein in your arm, the doctor or nurse may first have to apply a temporary tourniquet. This is to make it easier to put the needle into the vein.
• The dose you receive will depend both on the sort of test which is being done and on your body weight.
• Your doctor may need to add something called heparin to the blood samples, which she/he takes from you. This is to prevent the samples from clotting.
Recommended dosages (mg/kg = milligrams of medicine for each kilogram you weigh)
Single doses Adults (18 - 64 years), the elderly (65 years or more), adolescents and children (11 - 18 years):
• For investigating blood flow through the heart, brain, general blood circulation and micro-circulation, (for example, blood flows through parts of the eye, the choroid), the recommended dose is 0.1 - 0.3 mg/kg body weight.
• For assessing liver function, the recommended dose is 0.25 - 0.5 mg/kg body weight.
Maximum daily dose Adults and the elderly:
The total daily dose should be kept below 5 mg/kg body weight.
Adolescents and children:
• (11 - 18 years) : The total daily dose should be kept below 5 mg/kg body weight.
• (2 - 11 years): The total daily dose should be kept below 2.5 mg/kg body weight.
• (0 month - 2 years) : The total daily dose should be kept below 1.25 mg/kg body weight.
Use in children and adolescents
Single doses to be used in children and adolescents are the same as for adults but the total daily dose should be kept below 2.5 mg/kg body weight in children 2 - 11 years and below 1.25 mg/kg body weight in children 0 - 2 years.
Use in patients with kidney or liver impairment
Verdye should be dosed cautiously in the presence of severe kidney or liver impairment.
After the injection, your doctor may measure how much dye there is in relation to the amount of blood. Measurements are usually taken at an artery, a finger or an earlobe. You can ask your doctor to explain the techniques associated with your procedure.
If you use more of this medicine than you should Please tell your doctor if you think you have been given too much of the medicine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, Verdye can cause side effects, although not everybody gets them.
Severe allergic reaction: very rare (may affect up to 1 in 10,000 people)
The symptoms are:
• tightness in the throat
• itchy skin
• blotchy skin
• nettle-rash
• coronary artery spasm
• facial swelling (facial oedema)
• breathing difficulties
• tightness and/or pain in the chest
• faster heartbeat
• a fall in blood pressure and shortness of breath
• heart failure (cardiac arrest)
• restlessness
• feeling sick (nausea)
• feeling of warmth
• flushes
Together with the symptoms of the allergic reaction, an increase of special white blood cells associated with allergic reactions can occur (hypereosinophilia).
The possibility of an allergic reaction is greater in patients with extremely serious kidney failure.
In the case of a severe allergic reaction, it may be necessary for you to receive emergency treatment such as:
• injections of adrenaline (epinephrine), hydrocortisone or antihistamine,
• artificial blood or electrolyte solutions (by drip feed),
• oxygen, to help your breathing.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Keep the glass vials in the outer carton in order to protect from light.
Once the solution for injection is prepared, it must be protected from light and used immediately.
Only use clear solutions free from visible particles.
Do not use Verdye after the expiry date which is stated on the carton and on the label of the vial. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Verdye contains The active substance is indocyanine green.
Each vial contains:
either
25 mg indocyanine green as powder (to be reconstituted with 5 ml water for injections)
or
50 mg indocyanine green as powder (to be reconstituted with 10 ml water for injections)
What Verdye looks like and contents of the pack Verdye is a dark-green powder for solution for injection in an amber glass vial, which is sealed with a grey rubber stopper and fixed with an aluminium cap covered by a blue polypropylene cap.
It is available in two pack sizes:
• 5 vials, each containing 25 mg of indocyanine green
• 5 vials, each containing 50 mg of indocyanine green
Not all pack sizes may be marketed.
Marketing Authorisation Holder Diagnostic Green Limited, IDA Business & Technology Park
Garrycastle
Athlone
Co. Westmeath
N37 F786
Ireland
Website: www.diagnosticgreen.com T: +353 90 646 5499 Manufacturer Renew Pharmaceuticals Ltd., Athlone Business and Technology Park
Garrycastle
Athlone
Co. Westmeath
N37 F680
Ireland
This leaflet was last revised in 03/2023.
PIL00ICGUKXX
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Diagnostic Green Limited
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Verdye 5 mg/ml Powder for solution for injection comes as powder containing 5 mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Verdye 5 mg/ml Powder for solution for injection is indocyanine green.
Medicines with the same active substance include: Zyogreen 2.5 mg/ml Solution for injection. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Verdye 5 mg/ml Powder for solution for injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Ask anything about Verdye 5 mg/ml Powder for solution for injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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